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<SEC-DOCUMENT>0001096906-04-000436.txt : 20041012
<SEC-HEADER>0001096906-04-000436.hdr.sgml : 20041011
<ACCEPTANCE-DATETIME>20041012130211
ACCESSION NUMBER:		0001096906-04-000436
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20041012
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20041012
DATE AS OF CHANGE:		20041012

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			UTAH MEDICAL PRODUCTS INC
		CENTRAL INDEX KEY:			0000706698
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				870342734
		STATE OF INCORPORATION:			UT
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12575
		FILM NUMBER:		041074212

	BUSINESS ADDRESS:	
		STREET 1:		7043 S 300 WEST
		CITY:			MIDVALE
		STATE:			UT
		ZIP:			84047
		BUSINESS PHONE:		8015661200
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>utahmed8k101204.txt
<TEXT>
                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

                                    FORM 8-K

                       Pursuant to Section 13 or 15(d) of
                       The Securities Exchange Act of 1934



       Date of Report (date of earliest event reported): October 12, 2004


                           Commission File No. 0-11178
                                               -------


                           UTAH MEDICAL PRODUCTS, INC.
                           ---------------------------
             (Exact name of Registrant as specified in its charter)


                    UTAH                                87-0342734
       -------------------------------             ------------------
       (State or other jurisdiction of             (I.R.S. Employer
       incorporation or organization)              Identification No.)


                               7043 South 300 West
                               Midvale, Utah 84047
                               -------------------
                     Address of principal executive offices


Registrant's telephone number:      (801) 566-1200
                                    --------------


<PAGE>


- --------------------------------------------------------------------------------

                             ITEM 8.01 OTHER EVENTS

- --------------------------------------------------------------------------------

On October 12, 2004, Utah Medical Products, Inc. issued a press release
responding to on-going customer questions prompted by competitors. A copy of the
press release is attached hereto as Exhibit 99.1


- --------------------------------------------------------------------------------

                                   SIGNATURES

- --------------------------------------------------------------------------------

  Pursuant to the requirements of the Securities Exchanges Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.


                                            UTAH MEDICAL PRODUCTS, INC.
                                            ---------------------------
                                            REGISTRANT


Date:       10/12/04                        By:   /s/ Kevin L. Cornwell
      ----------------------                    -----------------------
                                                Kevin L. Cornwell
                                                CEO



- --------------------------------------------------------------------------------

                                  EXHIBIT INDEX


Index
Number         Description
- ------         -----------

99.1           Press release issued October 12, 2004: UTMD Responds to On-going
               Customer Questions Prompted by Competitors.

</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>utahmed8k101204ex99-1.txt
<TEXT>


                                  EXHIBIT 99.1


"The reports of my death are greatly exaggerated." ...Mark Twain

Salt Lake City, Utah - In August, Utah Medical Products, Inc. (Nasdaq:UTMD)
published a number of its own press releases in response to an August 10, 2004
press release from the U.S. Food & Drug Administration (FDA) which has unfairly
caused some concern regarding the continued use of UTMD's products. UTMD would
like to remind shareholders, customers and others that they can conveniently
find these press releases stating UTMD's position by accessing www.utahmed.com
on the Internet.

Unfortunately, UTMD's competitors, instead of appreciating that UTMD is also
challenging systemic deficiencies within the government that affect responsible
manufacturers in the device industry, have tried to take advantage of the
situation through innuendo to customers that UTMD may be imminently shut down.
This is false, as explained in more detail below.

In order to defend the interest of its stakeholders, not the least of whom are
patients that should not be denied UTMD's unique life-saving products, UTMD
wishes to refresh its position:

    >      Two months after the FDA press release, UTMD continues to
           manufacture and distribute all of its products worldwide without
           any regulatory restriction.
    >      There has been no mandated recall or any other regulatory
           enforcement action that restricts customers from using UTMD's
           products.
    >      There has not been, and is not now, any allegation by the FDA that
           UTMD's products are not safe or effective.
    >      There is no FDA claim of defective products or products not
           conforming to specifications.
    >      The proven extremely low product liability risk using UTMD's
           products has not changed.

The FDA, after completing four comprehensive inspections of UTMD's internal
quality system in three years, requested an injunction that would halt
production and distribution while the company fixes alleged "violations" which
have not yet been proven. UTMD, supported by a variety of independent respected
experts after evaluating its manufacturing practices, vehemently denies that
there are violations of the Quality System Regulation (QSR). UTMD seeks to
confirm decades of successful device manufacturing against a paper-driven FDA.

The FDA-483 forms submitted by inspectors after each inspection contain
"observations" which are not, according to the FDA's own policies, considered
"violations" by the agency until reviewed by superiors and linked to provisions
of the QSR. (See The Wall Street Journal, 9/29/04, "FDA Is Questioned on Report
About Red Cross Unit in Atlanta.") Since this dispute began in 2001, no reviewer
or superior from the FDA has ever identified or discussed with UTMD what is


<PAGE>


inadequate about any of UTMD's detailed written responses to FDA-483
observations, or any QSR linkages. The FDA-483 observations regarding UTMD's
documentation, remarkably, changed substantially from inspection to inspection
without any significant changes made by UTMD. In the latest 2004 inspection by
three inspectors over a five week time span, the number of FDA-483 observations
declined dramatically from the previous 2003 inspection, and those relating to
sterilization disappeared without any change to UTMD procedures.

A U.S. Federal Court in Salt Lake City will decide if the FDA's request for
injunction has any merit. The Court has set a schedule for discovery which will
lead to a trial, if it happens at all, no earlier than June 2005. Any reference
to an imminent shut down of UTMD is obviously false.

The paradox for UTMD's customers that is being unscrupulously exploited by
competitors is "How could this (the FDA's press release that UTMD is violating
the QSR) not be true?" UTMD asks other parties to consider whether the FDA is
always right in what it does. Interestingly, the FDA has not sought a
preliminary injunction against UTMD, which would be in the public interest if
there were a device quality issue. This appears to be virtually unprecedented in
a case where they seek such severe action against a company. It is also
interesting that the FDA appears to be in no hurry to have their claims
adjudicated, given they first requested a trial date in August 2005. Before we
arrive at the point in time for a trial, UTMD believes there will be other
public information that will reassure customers that an interruption in
distribution of UTMD's products will not happen.

Investors are cautioned that this press release contains forward looking
statements and that actual events may differ from those projected.

Utah Medical Products, Inc., with particular interest in health care for women
and their babies, develops, manufactures, assembles and markets a broad range of
disposable and reusable specialty medical devices designed for better health
outcomes for patients and their care-providers. For more information about Utah
Medical Products, Inc., visit UTMD's website at www.utahmed.com.



</TEXT>
</DOCUMENT>
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